Brand Name | ENDEAVOR SPRINT RX |
Type of Device | STENT, CORONARY, DRUG-ELUTING |
Manufacturer (Section D) |
MEDTRONIC IRELAND |
parkmore business park west |
galway |
|
Manufacturer (Section G) |
MEDTRONIC IRELAND |
parkmore business park west |
|
galway |
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 4643075 |
MDR Text Key | 16994731 |
Report Number | 9612164-2015-00449 |
Device Sequence Number | 1 |
Product Code |
NIQ
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | P090006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/17/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/20/2012 |
Device Catalogue Number | ENSP27530X |
Device Lot Number | 0005314355 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/17/2015
|
Initial Date FDA Received | 03/31/2015 |
Date Device Manufactured | 12/21/2010 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
Patient Age | 00056 YR |
|
|